Aortic Occlusion Balloon Apparatus, System and Method of Making

ABSTRACT

The disclosure sets forth various exemplary embodiments of systems, methods, and/or medical apparatuses including but not limited to: a sheath; and a balloon disposed at a working distal end of the sheath. According to one example embodiment the medical device can include where the sheath can include woven wire reinforcing axial and longitudinal strength, side holes, a one direction distal valve, and can include an inflator. According to one example embodiment the medical device can include where the sheath can include a narrow cross-section of, e.g., 7-8 Fr and balloon of length of, e.g., 12 cm.

BACKGROUND OF THE DISCLOSURE Technical Field of the Disclosure

The disclosure relates generally to treatment of aneurysms and trauma,and therapies seeking to reinforce, or occlude, a blood vessel. Althoughemphasis is given to repair of ruptured aneurysms and particularly iliacartery and abdominal aortic aneurysm (AAA), other embodiments aresuitable for applications in treating trauma patients.

Related Art

An abdominal aortic aneurysm (AAA) is a weak area in the aorta, a sac inan arterial wall caused by an abnormal dilation of the wall of theaorta, a major artery of the body, as it passes through the abdomen of apatient's body from heart toward the legs. The abdomen is a portion ofthe body which lies between the thorax and the pelvis. The abdomencontains a cavity, known as the abdominal cavity, separated by thediaphragm from the thoracic cavity and is lined with a serous membrane,the peritoneum. The aorta is the main trunk, or artery, from which thesystemic arterial system proceeds. The aorta arises from the leftventricle of the heart, passes upward, bends over and passes downthrough the thorax, through the abdomen to about the level of the fourthlumbar vertebra, where it divides into the two common iliac arteries.The normal diameter of the abdominal aorta is about one inch (25 mm),but blood vessels of smaller people, and the elderly can be smaller. Asblood flows through the aorta, the weakened area can bulge like aballoon and can burst (referred to as rupturing) if the balloon gets tooenlarged.

Most aortic aneurysms occur in the abdominal aorta, caused primarily byarteriosclerosis. This is a condition in which fatty deposits are laiddown in the walls of arteries, causing the blood vessel to becomeweakened and less elastic. Risk factors for arteriosclerosis includehigh blood pressure, smoking, and genetic factors. The AAA usuallyarises in the infrarenal portion of the arteriosclerotically diseasedaorta such as, for example, below the kidneys. When left untreated, anAAA can eventually cause rupture of the sac with ensuing fatalhemorrhaging in a very short time. High mortality associated withrupture of an AAA has led to the development of methods oftransabdominal surgical repair of abdominal aortic aneurysms. Surgeryinvolving the abdominal wall, however, is a major undertaking withassociated high risks. There is considerable risk associated with thissurgical intervention, which can involve replacing a diseased andaneurysmal segment of blood vessel with a prosthetic device which cantypically be a synthetic tube, stent, or graft, usually fabricated ofeither DACRON®, GORETEX®, or other suitable material. Examples of stentgraft systems include the ENDURANT II, stent grafts systems availablefrom Medtronic Corporation of Minneapolis, Minn. USA and/or a GORE®EXCLUDER® AAA Endoprosthesis, available from Gore Medical, a division ofW.L. Gore & Associates, Inc., Medical Products Division, Flagstaff,Ariz., USA.

A first conventional method of performing the surgical procedure, caninclude exposure of the aorta through an abdominal incision, which couldextend from the rib cage to the pubis. The aorta must be closed bothabove and below the aneurysm, so that the aneurysm can then be openedand the thrombus, or blood clot, and arteriosclerotic debris removed.Small arterial branches from the back wall of the aorta can be tied off.The DACRON® or GORETEX® tube, or graft, of approximately the same sizeof the normal aorta can be sutured in place, thereby replacing theaneurysm. Blood flow can then be reestablished through the graft. Withthis method, it can be necessary to move the intestines in order to getto the back wall of the abdomen prior to clamping off the aorta.

If the surgery is performed prior to rupture of the abdominal aortaaneurysm, the survival rate of treated patients is markedly higher thanif the surgery is performed after the aneurysm ruptures, although themortality rate is still quite high. If surgery is performed prior torupture of the aneurysm, the mortality rate is minimal. Conventionalsurgery performed after rupture of the aneurysm results in asignificantly higher mortality rate. Although abdominal aortic aneurysmscan be detected from routine examinations, patients do not experienceany pain from the condition. Thus, if the patient is not receivingroutine examinations, it is possible that an aneurysm can progress tothe rupture stage undetected.

Disadvantages associated with the first conventional surgery, inaddition to high mortality rate, include an extended recovery periodassociated with such surgery; difficulties in suturing the graft, ortube, to the aorta; loss of the existing thrombosis to support andreinforce the graft; unsuitability of the surgery for many patientshaving abdominal aortic aneurysms; and problems associated withperforming the surgery on an emergency basis after the aneurysm hasruptured. As to the extent of recovery, a patient can expect to spend 1to 2 weeks in the hospital after surgery, a major portion of which isspent in the intensive care unit, and a convalescence period at homefollows, particularly if the patient has other illnesses such as heart,lung, liver, and/or kidney disease, in which case the hospital stay canalso be lengthened. Since the graft must be secured, or sutured, to theremaining portion of the aorta, it can many times be difficult toperform the suturing step because of thrombosis present on the remainingportion of the aorta, and that remaining portion of the aortic wall maybe weakened.

More recently, a second conventional approach to repair an abdominalaortic aneurysm can include intraluminal graft delivery. Vascularsurgeons install an endovascular stent/graft delivered to the site ofthe aneurysm using elongated catheters threaded through a patient'sblood vessels, often over a wire. Typically, the surgeon makes a smallincision in the patient's groin area and inserts a delivery cathetercontaining a collapsed, self-expanding, or balloon expandablestent/graft to a location bridging the aneurysm, at which point thestent/graft can be delivered out from the distal end of the deliverycatheter and can be allowed or made to expand to approximately thenormal diameter of the aorta at that location. The stent/graft is atubular structure allowing blood flow through the lumen thereof andremoving pressure from the aneurysm. Over time the stent/graft canbecome endothelialized and space between the outer wall of the stent andthe aneurysm can fill with clotted blood. After installation, theaneurysm is no longer subjected to aortic pressure and thus will nolonger continue to grow. Intraluminal stent graft delivery does not havea relatively high mortality rate; does not have an extended recoveryperiod; does not require suturing the graft to the remaining aorta wall;permits existing thrombosis to support and reinforce the graft; issuitable for older patients; and is more readily performed on anemergency basis after rupture of the aneurysm.

Unfortunately patients who suffer from a ruptured AAA can experienceextensive internal bleeding, and an associated loss of blood pressure,that can lead to brain injury. Thus, what is needed is an improvedmethod of occluding blood flow caused by a ruptured aneurysm ortraumatic injury to prevent brain injury and to allow implantation ofimplantable stent graft in the ruptured portion of the aorta.

In a trauma setting, limiting or stopping blood flow through the majorblood vessel of the body, the aorta, is an established method forslowing the rate of blood loss in a severely injured patient withongoing bleeding. In the military, this aortic occlusion hastraditionally been achieved using a large aortic clamp inserted into thechest cavity via a large incision between the ribs. This extremelyinvasive maneuver is often reserved only for the sickest patients whohave lost vital signs. Clamping the aorta excludes the systemiccirculation, by definition, thus causing an ischemia. The goal of aorticclamping is to keep the patient's remaining blood circulating to theheart, lungs, and brain until bleeding below the aortic clamp iscontrolled and the patient can be resuscitated and systemic circulationrestored.

Recently, balloon catheters used in endovascular surgery have beenrepurposed to occlude the aorta by inflation of a balloon in the lumenof the aorta, as an alternative to aortic clamping. This procedure isreferred to as resuscitative endovascular balloon occlusion of the aorta(REBOA). REBOA has potential to achieve effective aortic occlusion.Therefore, REBOA may be used in a bleeding patient.

As with aortic clamping, REBOA can be used to increase blood pressure tovital organs while slowing ongoing blood loss. However, currentlyavailable FDA-approved balloon catheters used for REBOA can becomedislodged when blood pressure resumes due to bowing of the flexible stemof conventional balloon occlusion catheters. An example of this type ofdevice is disclosed in Eliason et al., U.S. Patent ApplicationPublication No. 2013/0102926, published Apr. 25, 2013, which isincorporated herein by reference in its entirety. As such, conventionalballoon occlusion has shortcomings. When aortic occlusion is used in thecourse of treatment of a hemorrhaging trauma patient, the physician mustalso begin to wean the patient off occlusion as early as possible. UsingREBOA, when the balloon is inflated, everything below the balloonquickly starts to die due to lack of blood flow. When the balloon isdeflated to initiate flow, hemodynamic collapse is possible.Additionally, variation in patient size (height, weight, aorticdiameter) limits the ability of a REBOA catheter to effectively occludeaortic flow in all patients.

What is needed is an improved solution that overcomes the shortcomingsof conventional solutions.

SUMMARY

The disclosure sets forth various exemplary embodiments of systems,methods, and/or medical apparatuses including but not limited to: asheath; and an elongate balloon occlude disposed at a working distal endof the sheath.

According to one example embodiment the medical device can include wherethe sheath can include but is not limited to: woven wire reinforcingaxial or longitudinal strength. In one exemplary embodiment, the wirecan be Nitinol, steel, or other commonly used medical wire.

According to one example embodiment the medical device can include wherethe sheath can include but is not limited to: a narrow cross-section.

According to one example embodiment the medical device can include wherethe narrow cross-section sheath can include but is not limited to anexternal cross-sectional diameter of at least one of: 5-10 Fr; 6-9 Fr;6-7 Fr; or 8 Fr or less.

According to one example embodiment the medical device can include wherethe sheath can include but is not limited to: at least one hole.

According to one example embodiment the medical device can include wherethe at least one hole of the sheath can include but is not limited to atleast one of: at least one side hole; a one-way valve; a one-way valveat a distal tip of the sheath; or a one-way valve on a distal end,distal to the balloon.

According to one example embodiment the medical device can include wherethe at least one hole of the sheath can include but is not limited to: aplurality of side holes; and a one-way valve on a distal end, distal tothe balloon.

According to one example embodiment the medical device can include wherethe sheath further can include but is not limited to: a lumen caninclude but is not limited to at least one channel for use in dispensingvia the at least one hole at least one of: a radio opaque dye; a radioopaque gas; a CO₂ gas; an anti-coagulant; a heparin injection; or adrug.

According to one example embodiment the medical device can include wherewherein the sheath further can include but is not limited to: a lumencan include but is not limited to at least one internal channel for usein dispensing at least one of: a radio opaque dye; anti-coagulant; or adrug.

According to one example embodiment the medical device can include wherethe balloon can include but is not limited to: wherein the balloon isrecessed in a cavity in the sheath.

According to one example embodiment the medical device can include wherethe balloon can include but is not limited to: wherein the balloon isintegrated coaxially in a cavity in the sheath.

According to one example embodiment the medical device can include wherethe balloon can include but is not limited to: wherein the balloon iscoupled to an inflator.

According to one example embodiment the medical device can include wherethe balloon and inflator are coupled together via at least one of:lumen; or inflation port.

According to one example embodiment the medical device can include wherethe inflator can include but is not limited to at least one of: asyringe; a compressed gas source; a fluid source; a CO₂ cartridge; ahypodermic syringe; a pressurized air; a pressurized gas; or apressurized liquid.

According to one example embodiment the medical device can include wherethe balloon can include but is not limited to: wherein the balloon hasan inflation diameter at least of one of: 10 mm-60 mm (30-150Fr); 15mm-48 mm (45-144Fr); or 44 mm (132Fr).

According to one example embodiment the medical device can include wherethe balloon can include but is not limited to: wherein the balloon hasballoon has a longitudinal length of at least one of: 9-15 cm(270-450Fr); or 12 cm (360Fr).

According to one example embodiment the medical device can furtherinclude but is not limited to: a lumen coupled to the sheath wherein thelumen is configured to: flush the sheath; or inject gas or fluid throughthe sheath.

According to one example embodiment the medical device can furtherinclude but is not limited to at least one of: a wire for passing themedical device through the vasculature of a patient; an introducer; anatraumatically tipped introducer; a rounded end introducer; anintroducer configured to introduce the medical device through thevasculature of a patient; an introducer configured to pass over a wirethe medical device;

According to one example embodiment the medical device can include wherethe woven wire can include but is not limited to: wherein the woven wireforms a mesh circumferentially embedded or adjacent to a lumen of thesheath.

According to one example embodiment the medical device can include wherethe sheath can include but is not limited to at least one polymermaterial can include but is not limited to at least one of: PS, ABS,SAN, PMMA, PPE, PP, PE, PA, PC, PET, PA, POM, PMP, PPP, PC-HT, PEI, PSU,PES, PPSU, PAI, PI, PVDF, ETFE, PCTFE, PTFE, ePTFE, PFA, LCP, PPS, PEEK,PEK, PEKEKK, FEP, PFA, nylon, fluoropolymer, LCP, or engineered plastic.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate exemplary, and nonlimiting embodiments andtogether with the description serve to explain the principles disclosedherein. In the drawings, like reference numbers may indicatesubstantially similar, equivalent, or exemplary elements, and the leftmost digits in the corresponding reference number indicate the drawingin which an element first appears.

The subject matter disclosed herein is particularly pointed out anddistinctly claimed as set forth in the claims at the conclusion of thespecification. The foregoing and other objects, features and advantageswill be apparent from the following detailed description taken inconjunction with the accompanying drawings, of which:

FIG. 1A depicts an exemplary embodiment of an exemplary drawing of anexemplary balloon sheath medical device, according to an exemplaryembodiment;

FIG. 1B depicts an exemplary embodiment of an exemplary left endorthogonal view drawing 110 of the exemplary balloon sheath medicaldevice, according to an exemplary embodiment;

FIG. 1C depicts an exemplary embodiment of an exemplary right endorthogonal view drawing of the exemplary balloon sheath medical device,illustrating an exemplary tip valve opening, according to an exemplaryembodiment;

FIG. 1D depicts an exemplary embodiment of an exemplary cross-sectionalview of an exemplary balloon sheath medical device, having exemplaryside holes, and illustrating an exemplary valve on a right distal tip,according to an exemplary embodiment;

FIG. 1E depicts an exemplary embodiment of an exemplary external sideview of an exemplary balloon sheath medical device illustratingexemplary longitudinal, axial strengthening wire wrapping, exemplaryside holes, exemplary inflated balloon stint, according to an exemplaryembodiment;

FIG. 2 depicts an exemplary embodiment of an exemplary drawing of anexemplary sheath medical device with exemplary side holes, according toan exemplary embodiment;

FIG. 3 depicts an exemplary embodiment of an exemplary drawing of anexemplary recessed integrated balloon sheath medical device with anexemplary valve, having an inflation device, such as, e.g., a CO₂cartridge or other inflator, according to an exemplary embodiment;

FIG. 4 depicts an exemplary embodiment of an exemplary drawing of anexemplary recessed integrated balloon sheath medical device having anexemplary one way valve on an exemplary tip, through which gas or othermaterial may be infused, according to an exemplary embodiment;

FIG. 5 depicts an exemplary embodiment of an exemplary drawing of anexemplary sheath medical device having an exemplary radio opaque tip andexemplary side holes, according to an exemplary embodiment;

FIGS. 6A and 6B (collectively referred to FIG. 6) depict exemplaryembodiments of exemplary drawings and, respectively, illustrating anexemplary left end view, and right end view, of an exemplary introducer,having an outer diameter, and a wire opening, according to an exemplaryembodiment;

FIG. 6C depicts an exemplary embodiment of exemplary drawing,illustrating an exemplary side view of the exemplary introducer havingan outer diameter, and a wire opening therethrough, with an exemplaryatraumatic rounded tip for introducing the exemplary sheath medicaldevice according to FIGS. 1-5, according to an exemplary embodiment;

FIG. 7 depicts an exemplary embodiment of exemplary drawing,illustrating an exemplary over-the-wire, balloon catheter, as may beused in combination with various exemplary embodiments of thedisclosure, according to an exemplary embodiment; and

FIG. 8 depicts an exemplary embodiment of exemplary drawing,illustrating an exemplary representation of a patient's peripheralarterial system, according to an exemplary embodiment.

DETAILED DESCRIPTION OF VARIOUS EXEMPLARY EMBODIMENTS

It is important to note that the embodiments disclosed are only examplesof the many advantageous uses of the innovative teachings herein. Ingeneral, statements made in the specification of the present applicationdo not necessarily limit any of the various claims. Moreover, somestatements may apply to some exemplary features but not to others. Ingeneral, unless otherwise indicated, singular elements may be in pluraland vice versa with no loss of generality. In the drawings, likenumerals refer to like parts through several views.

Overview

According to one exemplary embodiment, a rigid sheath can be providedalong with an integrated, elongated balloon occlusion catheter, in oneembodiment. In one exemplary embodiment, the elongated balloon occlusioncatheter can be shaped like a hotdog when blown up, to provideadditional external surface area to provide improved occlusion, ascompared to conventional stent graft occlusion balloon catheters. In oneexemplary embodiment, the rigid sheath can include a cross-sectionaldiameter of approximately in the range of, e.g., 7-9 Fr, significantlysmaller in diameter than a conventional sheath. In an embodiment, thesheath may be reinforced with metal wire to increase longitudinalstrength to avoid bowing when used in occluding blood flow in thethoracic region of the aorta, e.g., during treatment of trauma or AAA.In one exemplary embodiment, the improved occlusion balloon can includean elongated or oblong balloon of 10-14 cm, preferably about 12 cmlength along a longitudinal axis. According to an exemplary embodiment,rapid inflation/deflation can be achieved by an inflator such as, e.g.,but not limited to, or other gas, liquid, or fluid, hypodermic syringe,or the like. A compressed CO₂ cartridge, may be used as an inflator inone exemplary embodiment. According to an exemplary embodiment, therigid sheath can include one or more holes, which can be along a sideof, or at a distal working end, for example, for fluoroscopy, the use ofinfusing x-ray or radio opaque dye or gas, performing an angiogram, orinfusing heparin or other anti-coagulants, etc. According to oneexemplary embodiment, the rigid sheath can include a plurality of sideholes. According to another exemplary embodiment, the rigid sheath caninclude a one directional valve, preferably at a distal end, for use ininfusion of anticoagulants or other treatment, or may alternativelyinclude a radio opaque tip. In one embodiment, the one-directional valvemay be on a distal working tip of the rigid sheath, beyond theintegrated balloon of an exemplary embodiment.

In an exemplary embodiment, the sheath can be constructed of resilientstiff plastic, nylon, polymer, or other stiff material, but can be of asmall enough diameter, approximately 7-8 french to allow intraluminalendovascular deployment. In one embodiment, the medical device can beinserted, and later can be removed outside of an endovascular endograftstent, which may be implanted in the region of the common iliac. In oneexemplary embodiment, the sheath can be integrated with or, wrapped in awire mesh, such as, e.g., but not limited to, a Nitinol, shape memorymetal, or other wire material mesh, in order to provide increasedlongitudinal strength as compared to conventional sheaths. According toone exemplary embodiment, rather than using a hypodermic syringe and airfluid for inflating/deflating the balloon, as is conventional, anexemplary CO₂ cartridge can be provided to allow improved capabilitysuch as, e.g., but not limited to, for faster inflation, radio opacity,etc., to blow up the elongated balloon occluder.

In one exemplary embodiment, behind and the proximal to the balloon, thesheath may include one or more holes in the side of the wall of thesheath, to allow for an Angiogram, or radio image, etc., or allowinginfusion of heparin or other anti-coagulant, or other type of infusion,to be administered.

According to an exemplary embodiment, the distal end of the sheath mayinclude a one-way valve, to allow unidirectional flow out through adistal tip of the sheath. The distal end may be rounded or otherwiseatraumatic in shape, and the medical device, including the balloonoccluder and the sheath may be configured to be introduced, over a wire,using, e.g., but not limited to, a plastic atraumatically tippedintroducer, according to an exemplary embodiment.

Introduction

Intraluminal delivery of a graft stent up through the groin, can bedelivered over a wire up through a femoral artery of the leg up into thecommon iliac region, and up into the lower abdominal portion of theaorta. In order to allow for implantation of an endograft stent in thisregion, it may be helpful to occlude blood flow coming down from theupper thoracic region of the aorta, to allow blood pressure to increase,during treatment of a ruptured abdominal aortic aneurysm (AAA), and toavoid brain injury due to lack of blood flow to the brain due to theruptured AAA. According to an exemplary embodiment, a balloon occlusioncatheter can be delivered up to the thoracic region, and can be blownup, e.g., with air or with liquid from a syringe through a tube coupledto the balloon. The use of the balloon occlusion catheter, as noted, canbe used to prevent blood flow down the aorta, allowing resuscitationefforts, allowing graft stent implantation, and ensuring blood flow tothe patient's brain. Unfortunately, conventional aortic occlusionballoons tend to migrate caudally (toward the tail end of the body) dueto bowing of the flexible inflation lumen. According to an exemplaryembodiment, an improved occlusion balloon can be supported by a rigidsheath, conventionally a large (14-16 French (Fr) sheath, where three(3) French is roughly equivalent to a one (1) millimeter) size sheath.Unfortunately, such a large sheath cannot be used in a small patient ora patient with small arteries. Conventionally, as the patient recovers,because of increasing pressure of the blood being pumped by the heartdown through the aorta, the conventional flexible tubing attached to theballoon occlusion catheter can buckle or bow from the blood's pressure,causing the balloon to migrate and preventing the balloon from stayingin a fixed position, and preventing proper occlusion. According tovarious exemplary embodiments, various improvements are set forth hereinto overcome shortcomings of conventional small diameter balloonoccluders with flexible inflation lumens. Various disclosed exemplaryembodiments can overcome such shortcomings of conventional solutions,and may be used in treatment of ruptured AAA, as well as in a traumasetting to occlude blood flow in a trauma patient.

General Terminology

As will be apparent to those skilled in the art, the French scale orFrench gauge system is commonly used to measure the size of a catheter.The French scale is most often abbreviated as Fr (as it will behereafter referred to, herein), but can often be seen abbreviated as Fg,Ga, FR or F. It may also be abbreviated as CH or Ch (for Charrière, itsinventor). The French size is three times the diameter in millimeters.Thus, a round catheter of 1 French has an external diameter of ⅓ mm, andtherefore the diameter of a round catheter in millimeters can bedetermined by dividing the French size by 3, see, e.g., Equations 1A and1B:

D(mm)=Fr/3  Eq. 1A

Fr=D(mm)*3  Eq. 1B

For example, if the French size is 9, the diameter is 9/3=3.0 mm.

From the basic math equation for circumference (C)=ad, where d is thediameter of the circular cross-section, it follows that the catheter'scircumference in mm is only slightly (about 4.7%) greater than theFrench size.

An increasing French size corresponds to a larger external diameter.This is contrary to needle-gauge size, where an increasing gaugecorresponds to a smaller diameter needle.

The French size is a measure of the external diameter of a catheter (notinternal drainage channel). So, for example, if a two-way catheter of 20Fr is compared to a 20 Fr three-way catheter, they both have the sameexternal diameter but the two-way catheter will have a larger drainagechannel than the three-way. Three-way catheters accommodate an extrachannel for irrigation within a similar external diameter.

The French gauge was devised by Joseph-Frederic-Benoit Charrière, a19th-century Parisian maker of surgical instruments, who defined the“diameter times 3” relationship.

DETAILED DESCRIPTION

FIG. 1A depicts an exemplary embodiment of an exemplary drawing 100 ofan exemplary balloon sheath medical device 102, according to anexemplary embodiment. Exemplary balloon sheath medical device 102 caninclude, in one example embodiment, an example plastic tube sheath 104having an inner diameter 105, and an outer diameter 106. The balloonsheath medical device 102 can include the inner diameter wide enough toaccept an exemplary introducer 602 with a steering guide wire 632 asdepicted in exemplary FIG. 6, drawing 600, which can be used to guideand maneuver the exemplary balloon sheath medical device 102 to theupper thoracic region 810 (see FIG. 8) of the aorta, with a one-wayvalve 110 at a distal tip 111. to allow, e.g., but not limited to, forintroduction of a radio opaque (not permitting the passage of x-rays orother radiant energy) contrast medium that can be injected into thebody, according to an exemplary embodiment. The radio opaque contrastmedium may be introduced via catheter, to the upper thoracic region ofthe aorta, to facilitate radiographic imaging of internal structuresthat otherwise are difficult to visualize on x-ray displays, contrastmedia may be either radiopaque or radiolucent, according to an exemplaryembodiment. The balloon sheath medical device 102 catheter can includean exemplary wire wrap or support 107, in an exemplary embodiment,providing longitudinal axial strength, according to an exemplaryembodiment. The balloon sheath medical device 102 catheter can includean exemplary one or more holes 108, which may be on the side of theplastic tube sheath 104, or may be on an end or distal working end tip111, according to an exemplary embodiment. As shown, exemplary sheath104 may include an exemplary optional flush tube 118, according to oneexemplary embodiment.

Example plastic tube sheath 104, according to an exemplary embodiment,can be manufactured from any of various other polymer materials, as willbe apparent to those skilled in the relevant art, including, e.g., butnot limited to, PS, ABS, SAN, PMMA, PPE, PP, PE, PA, PC, PET, PA, POM,PMP, PPP, PC-HT, PEI, PSU, PES, PPSU, PAI, PI, PVDF, ETFE, PCTFE, PTFE,ePTFE, PFA, LCP, PPS, PEEK, PEK, PEKEKK, FEP, PFA, nylons,fluoropolymers, LCP, engineered plastics, and/or etc. Example materials,according to an exemplary embodiment, which may be used to manufacturevarious embodiments disclosed herein may include, e.g., but are notlimited to, medical device materials available from any of variousmedical device vendors including Ensinger GmbH, Wilfried-EnsingerStrasse 1, 93413 Cham, Germany. As illustrated by cut away 124, theballoon sheath medical device 102 can be substantial length to permitreaching up from a groin region 830, up to thoracic aorta region 810 asillustrated in FIG. 8.

Balloon sheath medical device 102, according to an exemplary embodiment,can further include, an exemplary inflator 112, which according to oneexemplary embodiment, can include one or more of a syringe, a hypodermicsyringe, a pressurized cartridge, a pressurized gas cartridge, acompressor, a liquid and/or gas compressor, pneumatic and/or fluid,and/or CO₂ cartridge, etc. Thus, inflator 112 can include, in oneembodiment a CO₂ cartridge, which can allow inflation of recessedballoon 116. Use of a CO₂ canister, according to an exemplaryembodiment, for inflation can ease rapid inflation of the balloonoccluder thus speeding up the procedure, as compared to conventionaltechniques.

According to an exemplary therapeutic endovascular use, the balloonsheath catheter medical device 102 can be used to inflate, via theinflator 112, the recessed balloon 116, according to an exemplaryembodiment, to allow sheath medical device 102 to remain in a constantposition to occlude blood flow, when the device is deployed in the upperthoracic region 810 of the aorta (see FIG. 8), to ensure blood flow tothe brain of a patient, during, e.g., implantation in the region of thecommon iliac 827 of an abdominal stent graft such as, e.g., but notlimited to, a GORE® EXCLUDER® AAA Endoprosthesis, available from GoreMedical, a division of W.L. Gore & Associates, Inc., Medical ProductsDivision, Flagstaff, Ariz., USA, or an ENDURANT® II, or an ENDURANTStent graft available from Medtronic Corporation.

Exemplary balloon sheath medical device 102 can further include,according to an exemplary embodiment, an example valve 110 on a distalend of the device, which can be a one way valve for infusion distal tothe balloon. According to an exemplary embodiment, the balloon 116 canwhen inflated allow sheath medical device 102 to remain in a constantposition to occlude blood flow, when the device is deployed in the upperthoracic region 810 of the aorta, to ensure blood flow to the brain of apatient, during, e.g., implantation of an abdominal stent graft,according to an exemplary embodiment.

Exemplary balloon sheath medical device 102 can further include, coupledto the exemplary inflator 112, various couplers, which can include beingcoupled via one or more tubes, lumen, and/or multi-lumen tubing, valves,and/or ports, and/or couplers, 114, 115, 120, 122 to an exemplaryrecessed balloon 116, according to an exemplary embodiment.

In one exemplary embodiment, the inflation couples 114, 115, 120, 122can run internal, integrated with, and/or external to plastic tubesheath 104. Exemplary plastic tube sheath 114 can be integrated into,internal to, external to, or adjacent to a side of plastic tube sheath104, and can be used to inflate, using example inflator 112, examplerecessed balloon 116, which as depicted can be placed in a recess oftubular sheath 104, according to an exemplary embodiment.

An exemplary recessed balloon 116, can in one embodiment be oblong inshape, oval, lengthened along one axis, tubular, or hotdog like inexternal volume, and/or can allow for delivery over a wire, similar to aconventional spherical balloon occlude catheter (see FIG. 7) such as,e.g., but not limited to, the RELIANT balloon catheter, available fromMEDTRONIC, of 710 Medtronic Parkway, Minneapolis, Minn. 55432 USA. Theballoon material can be of any exemplary medical grade material, suchas, e.g., but not limited to, vinyl, nitrile, latex, silicone rubber,synthetic rubber, natural rubber, and/or vinyl latex, etc., according toan exemplary embodiment.

FIG. 1B depicts an exemplary embodiment of an exemplary left endorthogonal view drawing 110 of the exemplary balloon sheath medicaldevice 102, according to an exemplary embodiment. Exemplary balloonsheath medical device 102 can include, in one example embodiment, anexample plastic tube sheath 104 having an inner diameter 105, and anouter diameter 106, with inner diameter wide enough to accept anexemplary introducer 602 with a steering guide wire 632 (as depicted inexemplary FIG. 6, drawing 600), which can be used to guide and maneuverthe exemplary balloon sheath medical device 102 to the upper thoracicregion of the aorta, according to an exemplary embodiment.

FIG. 1C depicts an exemplary embodiment of an exemplary right endorthogonal view drawing 120 of the exemplary balloon sheath medicaldevice 102, illustrating an exemplary valve opening 110 at workingdistal end tip 111, exemplary atraumatic blunt tip 111 with an orificeto accept steering guide wire 632, according to an exemplary embodiment.According to an exemplary therapeutic endovascular use, the balloonsheath catheter medical device 102 can be used to inflate, via theexemplary inflator 112, the exemplary recessed integrated balloon 116,with an inflated outer diameter 116A, having a recessed area or cavityin the sheath 104 that can house occlusion balloon 111, which can beblown up with the inflator 112 using, e.g., CO₂ so it could be inflatedand deflated rapidly, inner diameter 116B, to get to the balloon to besmaller, and length 126, longer in longitudinal axis than conventionalspherical balloon occluders to allow exemplary balloon sheath medicaldevice 102 to remain in a constant position to occlude blood flow,according to an exemplary embodiment. Exemplary balloon sheath medicaldevice 102 can include, in one example embodiment, an example plastictube sheath 104 having an inner diameter 105, and an outer diameter 106,with inner diameter wide enough to accept an exemplary introducer 602with a steering guide wire 632 as depicted in exemplary FIG. 6, drawing600, which is used to guide and maneuver the exemplary balloon sheathmedical device 102 to the upper thoracic region of the aorta, with anoptical one-way valve 110 at the distal end to allow for, e.g.,introduction of radio-opaque (not permitting the passage of x-rays orother radiant energy) contrast medium that can be injected into thebody, introduced via catheter, to the upper thoracic region 810 of theaorta, to facilitate radiographic imaging of internal structures thatotherwise are difficult to visualize on x-ray displays, contrast mediamay be either radiopaque or radiolucent, according to an exemplaryembodiment.

FIG. 1D (similar to FIG. 1A drawing 102, but an alternative embodiment)depicts an exemplary embodiment of an exemplary cross-sectional view 130of an exemplary balloon sheath medical device 102, having exemplary sideholes 108, exemplary atraumatic blunt, or rounded distal working end tip111 with one or more orifice(s) for steering guide wire 632, andillustrating an exemplary valve on a right distal tip, according to anexemplary embodiment. Exemplary balloon sheath medical device 102 caninclude, in one example embodiment, an example plastic tube sheath 104having an inner diameter 105, and an outer diameter 106, with innerdiameter 105 wide enough to accept an exemplary introducer 602 with asteering guide wire 632 as depicted in exemplary FIG. 6, drawing 600,which can be used to guide and maneuver the exemplary balloon sheathmedical device 102 to the upper thoracic region 810 of the aorta.According to an exemplary embodiment, the device 102 can include anexemplary one-way valve 110 at the tip 111 to allow for introduction ofe.g., but not limited to, radio-opaque (not permitting the passage ofx-rays or other radiant energy) contrast medium that is injected intothe body, introduced via catheter, to the upper thoracic region of theaorta, to facilitate radiographic imaging of internal structures thatotherwise are difficult to visualize on x-ray displays, contrast mediamay be either radiopaque or radiolucent. According to one exemplaryembodiment, device 102 can include an exemplary one or more wire wrap orstructural support 107, which can provide longitudinal and/or axialstrength, which can be on a surface or embedded within sheath 104,according to an exemplary embodiment. According to an exemplaryembodiment, the device 102 can further include, e.g., but not limitedto, an exemplary one or more holes 108, which may be on the side 108,109 of the plastic tube sheath 104, or on an end or tip 111, which maybe used to infuse gas or fluid such as, e.g., but not limited to, ananti-coagulant such as, e.g., heparin, etc. according to an exemplaryembodiment.

Example plastic tube sheath 104, according to an exemplary embodiment,can be manufactured from any of various other polymer materials, as willbe apparent to those skilled in the relevant art, including, e.g., butnot limited to, PS, ABS, SAN, PMMA, PPE, PP, PE, PA, PC, PET, PA, POM,PMP, PPP, PC-HT, PEI, PSU, PES, PPSU, PAI, PI, PVDF, ETFE, PCTFE, PTFE,ePTFE, PFA, LCP, PPS, PEEK, PEK, PEKEKK, FEP, PFA, nylons,fluoropolymers, LCP, engineered plastics, and/or etc. Example materials,which may be used to manufacture various embodiments disclosed hereinmay include, e.g., but not limited to, medical device materialsavailable from any of various medical device vendors including EnsingerGmbH, Wilfried-Ensinger Strasse 1, 93413 Cham, Germany, according to anexemplary embodiment.

Exemplary inflator 112, according to one exemplary embodiment, caninclude one or more of a syringe, a hypodermic syringe, a pressurizedcartridge, a pressurized gas cartridge, a compressor, a liquid and/orgas compressor, pneumatic and/or fluid, and/or CO₂ cartridge, etc. Thus,inflator 112 can include, in one embodiment a CO₂ cartridge, which canallow inflation of recessed balloon 116.

According to an exemplary therapeutic endovascular use, the balloonsheath catheter medical device 102 can be used to inflate via theexemplary inflator 112, the exemplary recessed integrated balloon sheath116, with an inflated outer diameter 116A, having a recessed area thatalong occlusion balloon could blow up with CO₂ so it could be inflatedand deflated rapidly, with a longer longitudinal axis balloon 116, innerdiameter 116B, the recessed area allowing the balloon to be smaller whendeflated, to allow withdrawal of exemplary balloon sheath medical device130 and of sufficient diameter to remain in a constant position toocclude blood flow, during, e.g., implantation of an abdominal stentgraft such as, e.g., but not limited to, a ANEURYX ENDURANT, or ENDURANTII, stent grafts systems available from Medtronic Corporation ofMinneapolis, Minn. USA and/or a GORE® EXCLUDER® AAA Endoprosthesis,available from Gore Medical, a division of W.L. Gore & Associates, Inc.,Medical Products Division, Flagstaff, Ariz., USA.

Exemplary balloon sheath medical device 102 can further include anexample one way valve 110, according to an exemplary embodiment, on adistal end of the device, according to an exemplary embodiment, to allowsheath medical device 102 to infuse fluid or gas such as e.g., but notlimited to, anti-coagulant e.g., heparin, etc., and an elongated balloon116 allowing device 102 to remain in a constant position to occludeblood flow, when the device is deployed in the upper thoracic region ofthe aorta, to ensure blood flow to the brain of a patient, during, e.g.,implantation of an abdominal stent graft such as, e.g., but not limitedto, an ENDURANT II, stent grafts systems available from MedtronicCorporation of Minneapolis, Minn. USA and/or a GORE® EXCLUDER® AAAEndoprosthesis, available from Gore Medical, a division of W.L. Gore &Associates, Inc., Medical Products Division, Flagstaff, Ariz., USA.

Exemplary balloon sheath medical device 102 can further include anexemplary inflator 112, which can be coupled via one or more tubes,lumen, and/or multi-lumen tubing, valves, and/or ports, and/or couplers,114, 120, 122 to an exemplary recessed balloon 116, according to anexemplary embodiment for ease of rapid inflation and/or deflation,according to an exemplary embodiment.

In one exemplary embodiment, the plastic tube conduit lumen 114, 115,117 can run internal, integrated with, and/or external to plastic tubesheath 104. Exemplary plastic tube sheath 114 can be integrated into,internal to, external to, or adjacent to a side of plastic tube sheath104, and can be used to inflate, using example inflator 112, examplerecessed balloon 116, which as depicted can be placed in a recess oftubular sheath 104, permitted eased extraction, particularly whenwithdrawing device 102 after graft implantation, according to anexemplary embodiment.

An exemplary recessed balloon 116, can in one embodiment be oblong inshape, oval, lengthened along one axis, tubular, or externally hot dogshaped and of longitudinal dimension of approximate 10-12 cm in length,and/or can allow for delivery over a wire, similar to a conventionalspherical balloon catheter such as, e.g., but not limited to, theRELIANT balloon catheter, available from MEDTRONIC, of 710 MedtronicParkway, Minneapolis, Minn. 55432 USA. The balloon material can be madeof any exemplary medical grade material, such as, e.g., but not limitedto, vinyl, nitrile, latex, silicone rubber, synthetic rubber, naturalrubber, and/or vinyl latex, etc., according to an exemplary embodiment.

FIG. 1E depicts an exemplary embodiment of an exemplary external sideview 140 of the exemplary balloon sheath medical device 102, also shownin FIG. 1A illustrating exemplary longitudinal axial strengthening wirewrapping 107, exemplary side holes 108, exemplary inflated recessedballoon catheter 116, according to an exemplary embodiment. As comparedto FIG. 1A, FIG. 1E illustrated wire wrapping distal to side holes 108and balloon 116 providing additional longitudinal strength as comparedto wire wrapping merely proximal to side holes 108 of FIG. 1A.

Exemplary balloon sheath medical device 140 can include, in one exampleembodiment, exemplary wire 107 providing longitudinal axial strength,exemplary one or more holes 108, exemplary inflator 112, exemplaryinflation tube 114, exemplary coupler 115, coupled internally orotherwise to exemplary inflated recessed balloon 116, according to anexemplary embodiment, which as depicted can be placed in a recess oftubular sheath 104.

FIG. 2 depicts an exemplary embodiment of an exemplary drawing 200 of anexemplary sheath medical device 202 illustrating exemplary longitudinalaxial strengthening wire wrapping 107, with exemplary side holes 108 ona distal end, and with an exemplary flush tube 118, according to anexemplary embodiment. According to exemplary embodiments, the device ofFIG. 3, or of FIG. 7 can be placed within the device illustrated in FIG.2 and/or FIG. 5, according to exemplary embodiments.

Exemplary balloon sheath medical device 202 can include, in one exampleembodiment, exemplary wire 107 providing longitudinal axial strength,exemplary one or more holes 108, exemplary flush tube 118 can be used toinfuse fluid, gas or otherwise coupled to exemplary sheath 104,according to an exemplary embodiment. The device 202 can be used alongwith a balloon occluder 702, such as that depicted and described, and asillustrated with respect to FIG. 7, below.

For further information with respect to FIG. 2, the reader is alsodirected to the description with reference to FIGS. 6A-6D, according tovarious exemplary embodiments.

FIG. 3 depicts an exemplary embodiment of an exemplary drawing 300 of anexemplary recessed integrated balloon sheath medical device 302 with anexemplary one way valve 110, at a distal tip 111 and having an exemplaryinflation device 112, an exemplary recessed inflated balloon 116,exemplary atraumatic blunt or rounded tip 111, according to an exemplaryembodiment. The balloon 116 can have a length of 8 cm-16 cm in oneembodiment, and 10-12 cm preferably, according to an exemplaryembodiment. According to an exemplary embodiment, the device illustratedin FIG. 3 can be made of an outer radius less than or close tosubstantially equal to an inner diameter of the device illustrated inFIG. 2, so as to allow the device of FIG. 3 to be used inserted withinthe device of FIG. 2, in an exemplary embodiment.

Exemplary balloon sheath medical device 302 can include, in one exampleembodiment, exemplary inflator 112, exemplary inflation tube 114,exemplary coupler 115, coupled internally to exemplary inflated balloonstint 116 with a length of about 10-12 cm, exemplary one way valve 110on a right side distal end tip 111, exemplary atraumatic blunt tip 111,according to an exemplary embodiment.

Example plastic tube sheath 302 can be manufactured, according to anexemplary embodiment, from any of various other polymer materials, aswill be apparent to those skilled in the relevant art, including, e.g.,but not limited to, PS, ABS, SAN, PMMA, PPE, PP, PE, PA, PC, PET, PA,POM, PMP, PPP, PC-HT, PEI, PSU, PES, PPSU, PAI, PI, PVDF, ETFE, PCTFE,PTFE, ePTFE, PFA, LCP, PPS, PEEK, PEK, PEKEKK, FEP, PFA, nylons,fluoropolymers, LCP, engineered plastics, and/or etc. Example materials,according to an exemplary embodiment, which may be used to manufacturevarious embodiments disclosed herein may include, e.g., but not limitedto, medical device materials available from any of various medicaldevice vendors including Ensinger GmbH, Wilfried-Ensinger Strasse 1,93413 Cham, Germany.

Exemplary inflator 112, according to one exemplary embodiment, caninclude one or more of a syringe, a hypodermic syringe, a pressurizedcartridge, a pressurized gas cartridge, a compressor, a liquid and/orgas compressor, pneumatic and/or fluid, and/or CO₂ cartridge, etc. Thus,inflator 112 can include, in one embodiment a CO₂ cartridge, which canallow inflation of recessed balloon 116.

According to an exemplary therapeutic endovascular use, the balloonsheath catheter medical device 302 can be used to inflate via theinflator 112, the exemplary recessed integrated balloon sheath 116,having a recessed area that along occlusion balloon 116 could blow upwith CO₂ so it could be inflated and deflated rapidly, e.g., but notlimited to, an ENDURANT Stent graft, or ENDURANT II, stent graftssystems available from Medtronic Corporation of Minneapolis, Minn. USAand/or a GORE® EXCLUDER® AAA Endoprosthesis, available from GoreMedical, a division of W.L. Gore & Associates, Inc., Medical ProductsDivision, Flagstaff, Ariz., USA.

Exemplary balloon sheath medical device 302 can further include anexample valve 110 on a distal end of the device, according to anexemplary embodiment, to allow sheath medical device 302 to remain in aconstant position to occlude blood flow, when the device is deployed inthe upper thoracic region 810 of the aorta, to ensure blood flow to thebrain of a patient, during, e.g., implantation of an abdominal stentgraft such as, e.g., but not limited to, an ENDURANT (ID II, stentgrafts systems available from Medtronic Corporation of Minneapolis,Minn. USA and/or a GORE® EXCLUDER® AAA Endoprosthesis, available fromGore Medical, a division of W.L. Gore & Associates, Inc., MedicalProducts Division, Flagstaff, Ariz., USA.

For further information with respect to FIG. 3, the reader is alsodirected to the description with reference to FIGS. 6A-6D, according tovarious exemplary embodiments.

Exemplary balloon sheath medical device 302 can further include anexemplary inflator 112, which can be coupled via one or more tubes,lumen, and/or multi-lumen tubing, valves, and/or ports, and/or couplers114, 115, to an exemplary recessed balloon 116, according to anexemplary embodiment.

An exemplary recessed balloon 116, can in one embodiment be oblong inshape, oval, lengthened along one axis, tubular, or hotdog like inexternal volume, and can be 10-12 cm and/or can allow for delivery overa wire 632, similar to a conventional spherical balloon catheter suchas, e.g., but not limited to, the RELIANT balloon catheter, availablefrom MEDTRONIC, of 710 Medtronic Parkway, Minneapolis, Minn. 55432 USA.The balloon material can be of any exemplary medical grade material,such as, e.g., but not limited to, vinyl, nitrile, latex, siliconerubber, synthetic rubber, natural rubber, and/or vinyl latex, etc.

FIG. 4 depicts an exemplary embodiment of an exemplary drawing 400 of anexemplary recessed integrated balloon sheath medical device 402 havingan exemplary one way valve 110 on an exemplary tip 111, exemplaryrecessed inflated balloon stint 116, exemplary atraumatic blunt tip 111,according to an exemplary embodiment, through which gas 404 CO₂ or othermaterial such as, e.g., but not limited to, anti-coagulants likeheparin, etc. e.g., CO₂ may be infused, according to an exemplaryembodiment.

Exemplary balloon sheath medical device 402 can include, in one exampleembodiment, a one-way valve 110 at the distal tip 111 to allow for,e.g., infusion, or introduction of radio-opaque (not permitting thepassage of x-rays or other radiant energy) contrast medium that isinjected into the body, introduced via catheter, to the upper thoracicregion 810 of the aorta, to facilitate radiographic imaging of internalstructures that otherwise are difficult to visualize on x-ray displays,contrast media may be either radiopaque or radiolucent, exemplaryrecessed inflated recessed balloon 116, exemplary atraumatic blunt tip111 which may allow easier maneuvering of sheath throughout the artery.

FIG. 5 depicts an exemplary embodiment of an exemplary drawing 500 of anexemplary sheath medical device 502 having an exemplary axiallongitudinal wire wrap (could even be parallel to the longitudinal axis)107, exemplary sheath 506, exemplary side holes 108, exemplaryatraumatic blunt tip 111, exemplary flush tube 118 coupled to sheath506. exemplary radio opaque tip 504, according to an exemplaryembodiment. According to exemplary embodiments, any other embodimentsmay include a radio opaque tip, according to an exemplary embodiment.

Exemplary balloon sheath medical device 502 can include, in one exampleembodiment, axial longitudinal wire wrap (could even be parallel to thelong axis) 107, exemplary sheath 506, exemplary side holes 108,exemplary atraumatic blunt tip 111, exemplary flush tube 118 coupled tosheath 506. exemplary radio opaque tip 504, according to an exemplaryembodiment.

Exemplary balloon sheath medical device 502 can be used to providestiffness to an existing balloon occlude 702 (as discussed further belowwith reference to FIG. 7) for delivery over a wire 632, similar to aconventional spherical balloon occlude catheter 702, such as, e.g., butnot limited to, the RELIANT balloon occluder catheter, available fromMEDTRONIC, of 710 Medtronic Parkway, Minneapolis, Minn. 55432 USA.

FIGS. 6A and 6B (collectively referred to FIG. 6) depict exemplaryembodiments of exemplary drawings 600 and 610, respectively,illustrating an exemplary left end view 610, and right end view 620, ofan exemplary introducer 602, having an outer diameter 634, and a wireopening 636 or receiving wire 632, according to an exemplary embodiment.The reader is directed to the description with reference to FIG. 2, andFIG. 3 in reviewing the contents of FIGS. 6A-6D, according to variousexemplary embodiments.

FIG. 6C depicts an exemplary embodiment of exemplary side view othegonaldrawing 620, illustrating an exemplary side view 630 of the exemplaryintroducer 602 having an outer diameter 634, and a wire opening 636therethrough, with an exemplary atraumatic rounded tip 111 forintroducing the exemplary sheath medical device 102 according to FIGS.1-5, according to an exemplary embodiment.

FIG. 7 depicts an exemplary embodiment of exemplary drawing 700,illustrating an exemplary over-the-wire, balloon occluder catheter 702,as may be used in combination with various exemplary embodiments of thedisclosure, according to an exemplary embodiment, illustrating aconventional spherical balloon catheter such as, e.g., but not limitedto, the RELIANT balloon catheter, available from MEDTRONIC, of 710Medtronic Parkway, Minneapolis, Minn. 55432 USA, according to anexemplary embodiment. According to an exemplary embodiment, the balloonoccluder catheter 702, may include balloon 710, and including a wire 632via hole 712 at end 632 b of the wire, and a hole 714 allowing end 632 aof wire 632 to pass through the end 714, and infuser port 708, tube 706and side port 704 of the balloon occlude catheter 702, according to anexemplary embodiment.

According to an exemplary embodiment, the balloon occlude catheter 702can be used in combination with the device as depicted, in e.g., but notlimited to, FIG. 2 and/or FIG. 5, according to exemplary embodiments.

FIG. 8 depicts an exemplary embodiment of exemplary drawing 800,illustrating an exemplary representation of a patient's peripheralarterial system, according to an exemplary embodiment. Exemplaryembodiment of exemplary drawing 802, illustrating an exemplaryrepresentation of a patient's peripheral arterial system which, caninclude, among other arteries, exemplary common carotid arteries 802;exemplary subclavian artery 804; exemplary aortic arch 806; exemplarycoronary artery 808; exemplary thoracic aorta 810; exemplary branches ofthe exemplary celiac trunk 814: exemplary left gastric artery 816,exemplary common hepatic artery 818, exemplary splenic artery 820; renalartery 822; radial artery 824; ulnar artery 826; common iliac 827;internal iliac artery 828; groin 830, and diaphragm 812 according to anexemplary embodiment.

General Background on AAA

When a patient has a ruptured aneurism and the patient is bleeding todeath in the lower abdominal region a vascular surgeon will want to tryand fix the aneurysm by installing an endograft stent, which involvesentering from the patient's groin 830 (see FIG. 8) with a catheter,often delivered over a wire, and deploying, and fixing the graft stentremotely in the patient's abdomen, e.g., in the region of a rupturedaorta, e.g., in the area of the common iliac fork 827, according to anexemplary embodiment.

Sometimes what the surgeon must do, if performing abdominal surgery totreat a ruptured AAA, after opening the patient's belly up at the levelof the diaphragm 812 the surgeon may put a clamp on the aorta 806, 810,according to an exemplary embodiment.

If the surgeon is going to be do this remotely, without opening thepatient's abdomen, by, e.g., catheter through the groin, then thesurgeon has to occlude the aortic artery, from inside the vascularsystem.

To treat a ruptured AAA, Applicant, an endovascular surgeon, inperforming this procedure tried to place an endograft stent up from thegroin 830 into the abdomen of the patient who is bleeding to deathbecause the patient's aneurysm has ruptured. The vascular surgeon put awire into the upper thoracic region of the aorta 810 and can insert asheath over the wire, e.g., with a retractable introducer. Then aballoon occlusion catheter such as, e.g., but not limited to, that shownin FIG. 7 was attempted to be placed over the wire, and placed up intothe upper thoracic aorta 810, above the level of the belly, i.e., abovewhere the bleeding is occurring from the rupture, because the bloodpressure in such a patient is very low from the internal bleeding. Afteroccluding blood flow by inflating the balloon, the patient's bloodpressure started to come up. Then, the conventional balloon catheter wasfound to bow caudally, getting pushed down with each heartbeat, and maybecame dislodged, preventing proper occlusion. So, to address this, theApplicant attempted overcoming this shortcoming of conventional balloonoccluders by using a stiffer wire, but the same thing happened. Thus, tofurther address this, the Applicant surgeon attempted to put a bigger,larger flexible sheath up to support the balloon occluder, but still thesame thing happened, i.e., the balloon migrated down from thebloodpressure. Meanwhile the patient was not doing well. So, finally theApplicant surgeon resorted to using a very large (approximately 28 Fr.)stiff sheath to attempt to support the balloon, which because of itslarge cross-sectional diameter would be hard to put up in most patients,but which in this particular patient, the Applicant did manage to getup. Then the Applicant vascular surgeon, who was supporting the ballooninflated the balloon up through the sheath and wedged the balloon inplace with the stiff sheath so that the balloon occluder wound not fall.

After considering the shortcomings of his makeshift solution, theApplicant surgeon conceived of a better solution, as set forth herein.The solution, according to an exemplary embodiment, is to provide animproved occlusion device, which does not migrate when inflated.According to one embodiment the Applicant surgeon conceived of a medicaldevice with a stiff sheath of less diameter than the larger stiff 28 Frsheath previously used. In one exemplary embodiment, a small sheath suchas that illustrated in FIG. 5, for example, with less diameter, e.g.,7-8 Fr, that is made of less thick than conventional rigid sheaths, butstill of stiff plastic, stiffened by, e.g., but not limited to, a wirewrap on or embedded wiring in, the improved stiff sheath to providerigidity, but with a smaller cross-section than conventional sheaths toallow for use in treatment of patients with, e.g., but not limited to,smaller vasculature, including that of, e.g., but not limited to, theelderly and patients of smaller stature or size. In one exemplaryembodiment, a conventional balloon occluder catheter, such as, e.g., butnot limited to, as shown in FIG. 7, can be supported by the improvedstiffened sheath allowing use of the conventional occlude, and canprovide additional features and advantages. In another exemplaryembodiment, an improved balloon, of greater length along a length axisthan conventional spherical balloon catheters, can be integrated invarious exemplary embodiments, in an improved sheath, as disclosedherein.

In another embodiment, a sheath can be wire wrapped like thatillustrated in FIG. 5, but can also include a balloon integratedtogether with the sheath, on or about the sheath, as opposed to thesebeing two different things. The integrated sheath, having a smallerdiameter than conventional stiff sheaths, which can be strengthenedwith, e.g., but not limited to, a wire mesh, etc., to give the sheathlongitudinal support. Also, by elongating the balloon, as compared toconventional balloon occluders, say, e.g., but not limited to, 8-16 cm,10-12 cm, or approximately 12 cm, were four times longer thanconventionally, in an exemplary embodiment. The elongated balloon, hasan advantage of having more surface area in contact with the wall of thevasculature, and can have greater surface contact to keep it in place,than the relatively small area of contact of a conventional balloon. Alarger contact area in the thoracic aorta, according to an exemplaryembodiment, can maintain the balloon occluder's and/or sheath'sposition, when longer in the longitudinal direction, for a length ofapproximately 10-12 cm, in one exemplary embodiment.

The example narrow stiff sheath, that is not as wide as conventional,but that has a wire wrap for longitudinal and/or axial stiffness, and anelongated balloon of approximately 12 cm exemplary length, and of whichone can inflate an occluder balloon, can further include one or moreside holes see FIG. 2 or FIG. 1A, 108, for example.

According to one exemplary embodiment, one can inject x ray dye to takepictures through hole(s) 108 or tip 111, see, e.g., but not limited to,FIG. 4. A one-way valve 110, 111, which in an embodiment can be at thedistal tip of the sheath that when dye is injected can allow the dye tocome out at a distal end, proximal to the balloon (at the side holes108), or distal to the balloon, out the tip 111, in one embodiment.

Also, to help reduce the size of the sheath, according to one exemplaryembodiment, a carbon dioxide inflation system 112, or other compressedgas, can be used to blow up/inflate the occluder balloon 116 as CO₂, asopposed to air or water, and an x-ray medium, which can require thediameter to be higher because the diameter necessary to get fluid up hasto be greater because water is a fluid and is fairly viscous when thereis x-ray dye mixed in it.

According to one embodiment Carbon Dioxide (CO₂) is a better solution,i.e., for inflation, because it shows up on an x-ray and may be used asan x-ray radio opaque medium when a patient has renal insufficiency,according to one exemplary embodiment.

An intra-aortic balloon pump, or angioballeen pump can be used tosupport a patient whose hemodynamics are bad, according to one exemplaryembodiment. If a patient is really sick, a cardiologist can use aballoon pump and can use carbon dioxide to take a radio or x-ray picturebecause CO₂ enters and exits very quickly, according to one exemplaryembodiment.

According to an exemplary embodiment, a roughly 7 to 8 Fr sheath can beprovided as illustrated in FIG. 1, for example, and is shortened withexample cutaway 124, to show example details of the exemplary workingend. The end 111, according to an exemplary embodiment, can have anexample one-way valve at the distal working end, i.e., distal to theballoon, and an embodiment of the sheath can have a recessed area thatcan house an exemplary elongated occlusion balloon 126, which can beinflated with CO₂, e.g., so it could be inflated rapidly and can be of alower Fr cross-section, and can include optional hole(s) along the sidesof the sheath, proximal to the balloon, and can have increased surfacearea contact with the vasculature side wall, due to its elongatedballoon 126, and the exemplary recesses of one embodiment, can allow theballoon to be deflated and withdrawn, e.g., after implantation of astent. Side holes, according to an exemplary embodiment, can allow anAngiogram or imaging or heparin or other anti-coagulant, or other typeof infusion to be dispensed on a distal end, but proximal to theballoon, or via an example one way valve distal to the exemplaryelongated balloon, according to an exemplary embodiment.

The exemplary side holes before the balloon, and example one way valvedistal to the balloon, allow an angiogram to be performed distal towhere the balloon occludes the bloodglow, or alternatively, the hole(s)and/or valve can be used to allow infusion of a heparin solution, orsome type of anticoagulant, particularly, e.g., if used in traumasetting, according to an exemplary embodiment. The example longitudinalsupport wires, according to an exemplary embodiment, can, rather thanbeing woven as illustrated, can in the alternative be wrappedcircumferentially, and/or in a spiral like a spring, etc., according toan exemplary embodiment. The exemplary wiring can be be in an axialorientation, or can provide longitudinal support for the sheath.

FIG. 2 illustrates an exemplary longitudinal support with exemplary wovewires wire wrap to give the exemplary sheath longitudinal support, toprevent bowing or bending of the sheath when blood pressure gets higher,so when there is forward pressure, when the blood pressure comes up, theexemplary sheath, according to an exemplary embodiment, does not bow dueto the wire strengthener.

Exemplary Diameters for an Exemplary Sheath Medical Device

The exemplary sheath as illustrated in FIG. 1, can, in one exemplaryembodiment be in the 7-9 french range. Preferably, the sheath should beas small as possible to both provide the longitudinal support necessary,as well as to allow endovascular insertion via the groin. According toone exemplary embodiment, the sheath can be 7-9 french (3 french=1 mm)so probably 3-4 mm in external diameter. Thus, this cross-sectionaldiameter is substantially smaller than most conventional sheaths ofsufficient stiffness to support a balloon, without bowing. Variousexemplary embodiments of the disclosed invention can be used in treatingruptured abdominal aneurysms and could also potentially have a role inproviding balloon occlusion, in trauma patients, and resuscitativeendovascular balloon occlusion of the aorta (REBOA), as well.

In a ruptured aneurysm, a vascular surgeon always positions the balloonoccluder above the thoracic aorta. The idea is to stop blood flow to thelower extremities or the lower areas, to allow resuscitation to takeplace by anesthesia, to let fluids go in, to allow blood pressure to getback up, to allow blood pressure to be high enough to maintain bloodflow to brain, which is the organ most susceptible to damage from therupture. Thus, the occlusion arrests blood flow in the lower part ofbody so anything coming out of the heart will be pumped upwards, andmaintains blood pressure to the brain, so brain injury is prevented.

In the case of resuscitative endovascular balloon occlusion of the aorta(REBOA) some endovascular balloon occlusion, is used in traumasituations. In the case of REBOA catheters, again conventional balloonsare similar to the spherical balloon illustrated in FIG. 7, which do nothave sufficient surface area to maintain position, and also lack a rigidsheath. According to an exemplary embodiment, a narrow rigid, non-bowingsheath can be provided and preferably with an integrated balloon, wherethe integrated balloon is an elongated balloon, of a minimum of 9 cm inlength, in a range of approximately 10-16 cm, or more, in length, andpreferably about 12 cm or more in length as illustrated in FIG. 3, andof a sufficient cross-sectional inflated diameter to fully occlude bloodflow in the thoracic aorta, for example, of approximately 27-34 mm,about 30-40 mm, or up to 48 mm to provide for enhanced surface areacontact, or up to 40-55 mm in diameter where the aorta is dilated oraneurysmic, according to an exemplary embodiment of the disclosure.

The one-way valve in various embodiments prevents blood from enteringthe sheath, according to an exemplary embodiment. The one-way valve ispreferably at a distal end, beyond the balloon, so that when fluid isinjected, the fluid can be ejected from the one-way valve distal to theballoon, as well as coming out the side holes before the balloon, aswell, according to an exemplary embodiment. An exemplary lumen or tubecan be used to inject fluid and/or the x-ray medium, according to anexemplary embodiment, and the fluid could come out of holes of thesheath behind the level of where the balloon is, according to anexemplary embodiment.

The balloon can be longer than conventional balloons, such as, e.g., butnot limited to 12 cm in elongated form, surrounding the outside of thesheath, and can in certain embodiments, when deflated be recessed toease when withdrawing the sheath after completion of the occlusion, anddeflation of the balloon, according to an exemplary embodiment.

According to an exemplary embodiment, the balloon occlude can beinflated preferably with a separate and/or coupled, and/or connected byone or more tubes, ports, and/or valves, inflator, which can include,e.g., but not limited to, a gas inflator, such as, e.g., but not limitedto, a CO₂ cartridge inflator 112, which could have one or more tube(s)114, 120 122 running to allow the balloon 116 to inflate, as illustratedin FIGS. 1 and 3.

Because the balloon 116, according to an exemplary embodiment, isexternal one doesn't need to worry about interference of the sheath.

The wrapping wire, woven wire, and/or support wire and/or supportstructure preventing bowing of the sheath, in one exemplary embodiment,can end just below where the balloon is, just stopping at, or stoppingsomewhere close to, where the side hole(s) 108 can be placed asillustrated, e.g., in FIGS. 1A, 1E, 2 and/or 5, according to variousexemplary embodiment.

The tubular sheaths, according to various exemplary embodiments can bemade of some combination of plastic, some sort of polymer, any ofvarious well known materials appropriate for surgical applications suchas, e.g., but not limited to, a plastic and/or rubber and/or nylonand/or stiff plastic that is not prone to bending, but of sufficientlysmall cross section to be appropriate for endovascular insertion.

FIG. 6 sets forth an exemplary introducer, the thing that allows one topass a device over a wire, (the introducer has a small diameter holethrough its center allowing the introducer to be guided over a smalldiameter wire). The introduce allows a medical device to be deliveredendovascularly over a wire and not have the medical device be blunt. Anintroducer would be used to provide the medical device over the wire.After insertion of the device, the introducer can be withdrawn leavingthe medical device positioned where desired, such as, e.g., in thethoracic aorta. The introducer would have a rounded, non-atraumaticpoint, one that is less pointed, more blunt.

The introducer sheath could have something that could go through themiddle of the sheather, that is safe so as not to damage the sheath, orone way valve at the distal end of the sheath, there could be a mark ona proximal end to indicate where the introducer should not be pushed anyfurther forth so that the surgeon inserting the medical device can knowthat the tip of the introduce can extend out only partially through thetip of the sheath, just barely out through the one way valve so that thedevice can be provided over a wire using the introducer, according to anexemplary embodiment.

An adjunct, according to an exemplary embodiment, can be to try tomaintain hemodynamics in a patient whose hemodynamics are deteriorating,or unstable. Primarily whern caused by a ruptured aneurysm, but also thecase of a trauma patient (e.g., in the REBOA application).

In the case of trauma patients there is about a 10% chance of blot clotsforming down in the lower part of the body after they use a balloonocclude catheter. Although a trauma patient may be being treated, aphysician can provide a low dose of blood thinner administeredintra-arterially to mitigate some of the risk of blood clots forming inthe lower abdomen from the use of the balloon occluder, according to anexemplary embodiment. The 10% incidence is significant and the sideholes and/or one way valve can provide an option to allow infusion ofe.g., anti-coagulants, and/or other injection such as, e.g., but notlimited to, a saline infusion, or to keep a little flow distal to wherethey are using the occlusion balloon.

When treating a ruptured aneurysm, a surgeon can administer ananti-coagulant such as, e.g., but not limited to, heparin, which can becirculated throughout the body. One might not do this if the applicationwere in a trauma setting, but there can be some situations as noted,where a low dose may be useful, according to an exemplary embodiment.

The balloon, according to an exemplary embodiment, could be a littlerecessed such as in a cavity as shown in FIG. 1A (in the sheath 104)along the side so when the balloon 116 is deflated after no longerneeded, the whole medical device 102 can be pulled back down the (out)side the endograft that has been already deployed. So, you might have asituation where the endograft was up, and the balloon has been insertedgoing e up alongside external but adjacent to the endograft stent, andafter deploying the graft the surgeon wants to be able to pull themedical device 102 back down and get it back out. So, by recessing theballoon in a slight cavity in the sheath, in an area 126, which is alittle bit recessed, so that the balloon when deflated is relativelyflush with the outer diameter 106 of the sheath medical device 102,according to an exemplary embodiment. Thus, the device 102 can be pulledback and because the balloon 116 is recessed when deflated, the balloondoes not catch on the graft when retracted alongside the stent.

Summary

Thus, the idea was conceived when Applicant was treating a patient witha ruptured aneurysm, the patient's blood pressure was really low, whiledelivering standard RELIANT vascular aortic balloon occluder. As thepatient's blood pressure came up, the catheter was bowing back uponitself and pushing back down into the aneurysm itself. The treatmentrequired multiple manipulations, and ultimately it required delivery ofa pretty large sheath approximately 24Fr, to buttress a balloon occluderat the back of the balloon with the large diameter sheath.Conventionally Applicant was able to amalgam several systems to attemptto accomplish this, but only by combining together a very large, stiffsheath (less than optimal) and a conventional spherical balloonoccluder, but certainly nothing is available as set forth in the variousexemplary embodiments set forth in this disclosure; i.e., nothing isavailable, which is as clean, nor integrated, nor as low profile as setforth herein. Also, conventionally one has to go up fairly high on asheath size to get something delivered that can actually support aballoon, and that is a problem if a patient has small arteries.Typically, a small or lower profile system that accomplishes the sameresult is better than something that is larger. In an exemplaryembodiment, an improved sheath of 6-7Fr diameter can be provided withwire support to provide longitudinal strength. In one embodiment, theballoon can be 12 cm long, as opposed to 2 cm-3 cm for the RELIANTballoon shown in FIG. 7. With an elongated balloon, there is a lot morecohabitation against the wall of the aorta or the vessels where theocclusion is taking place.

The balloon according to an exemplary embodiment would be an elongated,oval balloon with an elongated dimension of 10-16 cm, and thereforeincreased surface are in contact with the vascular wall. The ballooncould otherwise be somewhat like the RELIANT Balloon Occluder 702,available from Medtronic of Minneapolis, Minn. USA, i.e., there would bea hole 712 down the end of the tip of the balloon 710 occluder, howeverthe balloon of the disclosure would be an elongated, hot dog shapedballoon (not shown in FIG. 7), according to an exemplary embodiment. Awire 632 b that can go through the holes 712, 714 and there can beseparate side ports and/or valves and/or lumen 704,706, 708 that can beused to inflate the balloon.

RELIANT Balloon 710 as illustrated, includes to the side an inflationport and there is a little connection between inflation port and wherethe balloon blows up, as opposed to this one. Applicant's balloonoccluder 102 can also include such a side port, which can be forinflation, or another side port can allow infusion, etc.

Further, a wire would go through device and serve to guide the device toits desired location to allow occluding bloodflow in the aorta, byinflating the elongated balloon as set forth in Applicant's claimedinvention. The wire 632 serves as a guide; the wire guides delivery ofthe medical device intravascularly to the general vicinity fordeployment.

Balloon occlusion can have a goal of stopping blood flow to the lowerextremities, to allow resuscitation to take place by, e.g., anesthestia,etc., allowing maintaining of blood flow to the brain. A role for aballoon occlusion in Trauma REBOA aspects, a low dose blood thinner maybe administered intra-arterially, or at least as a saline infusion, tokeep a flow distal to the occlusion.

As noted, the balloon would be recessed when deflated along the side ofthe sheath in a recess in the sheath, so that the sheath can be thenwithdrawn from the endograft. The balloon and sheath are alongside thegraft, and then when pulled back do not catch.

In the case of a ruptured aneurysm, low blood pressure, an elongatedballoon can be placed and supported by a stiff sheath, preferably ofsmaller cross-section but strengthened to support the exemplaryelongated balloon, which can then allow the patient's blood pressure tocome back up, while the stiff sheath can prevent the elongated balloonoccluder from bowing and losing occlusion. The exemplary sheath canbuttress the back of, or be integrated with the balloon so as to preventcaudal movement of the balloon, and to ease expeditious implant of agraft stent.

All examples and conditional language recited herein are intended forpedagogical purposes to aid the reader in understanding the principlesof the disclosure and the concepts contributed by the inventor tofurthering the art, and are to be construed as being without limitationto such specifically recited examples and conditions. Moreover, allstatements herein reciting principles, aspects, and embodiments, as wellas specific examples thereof, are intended to encompass both structuraland functional equivalents thereof. Additionally, it is intended thatsuch equivalents include both currently known equivalents as well asequivalents developed in the future, i.e., any elements developed thatperform the same function, regardless of structure.

What is claimed is:
 1. A medical device comprising: a stiffened sheath;and an elongated balloon occluder disposed at a working distal end ofsaid sheath.
 2. The medical device according to claim 1, wherein saidsheath comprises: woven wire reinforcing axial and longitudinalstrength.
 3. The medical device according to claim 1, wherein saidsheath comprises: a narrow cross-section.
 4. The medical deviceaccording to claim 3, wherein said narrow cross-section sheath comprisesan external cross-sectional diameter of at least one of: 5-10 Fr; 6-9Fr; 6-7 Fr; or 8 Fr or less.
 5. The medical device according to claim 1,wherein said sheath comprises: at least one hole.
 6. The medical deviceaccording to claim 5, wherein said at least one hole of said sheathcomprises at least one of: at least one side hole; a one-way valve; aone-way valve at a distal tip of said sheath; or a one-way valve on adistal end, distal to said balloon.
 7. The medical device according toclaim 5, wherein said at least one hole of said sheath comprises: aplurality of side holes; and a one-way valve on a distal end, distal tosaid balloon.
 8. The medical device according to claim 6, wherein saidsheath further comprises: a lumen comprising at least one channel foruse in dispensing via said at least one hole at least one of: a radioopaque dye; a radio opaque gas; a CO₂ gas; an anti-coagulant; a heparininjection; or a drug.
 9. The medical device according to claim 1,wherein said sheath further comprises: a lumen comprising at least oneinternal channel for use in dispensing at least one of: a radio opaquedye; anti-coagulant; or a drug.
 10. The medical device according toclaim 1, wherein said balloon comprises: wherein said balloon isrecessed in a cavity in said sheath.#
 11. The medical device accordingto claim 1, wherein said balloon comprises: wherein said balloon isintegrated coaxially in a cavity in said sheath.
 12. The medical deviceaccording to claim 1, wherein said balloon comprises: wherein saidballoon is coupled to an inflator. #
 13. The medical device according toclaim 12, wherein said balloon and inflator are coupled together via atleast one of: lumen; or inflation port.
 14. The medical device accordingto claim 12, wherein said inflator comprises at least one of: a syringe;a compressed gas source; a fluid source; a CO₂ cartridge; a hypodermicsyringe; a pressurized air; a pressurized gas; or a pressurized liquid.#15. The medical device according to claim 1, wherein said ballooncomprises: wherein said balloon has an inflation diameter at least ofone of:# 10 mm-60 mm (30-150Fr);# 15 mm-48 mm (45-144Fr); or# 44 mm(132Fr).#
 16. The medical device according to claim 1, wherein saidballoon comprises: wherein said balloon has balloon has a longitudinallength of at least one of: 9-15 cm (270-450Fr); or 12 cm (360Fr). 17.The medical device according to claim 1, further comprising: a lumencoupled to said sheath wherein said lumen is configured to: flush saidsheath; or inject gas or fluid through said sheath.
 18. The medicaldevice according to claim 1, further comprising at least one of: a wirefor passing the medical device through the vasculature of a patient; anintroducer; an atraumatically tipped introducer; an rounded endintroducer; an introducer configured to introduce the medical devicethrough the vasculature of a patient; an introducer configured to passover a wire the medical device;
 19. The medical device according toclaim 2, wherein said woven wire comprises: wherein said woven wireforms a mesh circumferentially embedded or adjacent to a lumen of saidsheath.
 20. The medical device according to claim 1, wherein said sheathcomprises at least one polymer material comprising at least one of: PS,ABS, SAN, PMMA, PPE, PP, PE, PA, PC, PET, PA, POM, PMP, PPP, PC-HT, PEI,PSU, PES, PPSU, PAI, PI, PVDF, ETFE, PCTFE, PTFE, ePTFE, PFA, LCP, PPS,PEEK, PEK, PEKEKK, FEP, PFA, nylon, fluoropolymer, LCP, or engineeredplastic.